药物临床试验中研究者经济利益冲突的法律调控初探

Legal Regulation on the Financial Conflicts of Interests of Researchers in Drug Clinical Trials

目的:为我国制定药物临床试验中研究者经济利益冲突的法律调控措施提出建议。方法:分析临床试验中研究者经济利益冲突的概念及危害,并对美国食品与药品管理局调控研究者经济利益冲突的法律措施进行评介。结果与结论:我国可借鉴美国法的经验,制定调控研究者经济利益冲突的法律措施,明确研究者经济利益的定义,要求临床试验申请者披露研究者的经济利益,要求药品注册申请人向药监部门提供研究者经济利益冲突的声明。

OBJECTIVE： To put forward suggestions for the legal regulation on the financial conflict of interest of researchers in drug clinical trials. METHODS： The definition and harm of the financial conflict of interest of the researchers in clinical trials were analyzed, and the legal measures of FDA on regulating and controlling the financial conflict of interest of the researchers were evaluated. RESULTS ＆ CONCLUSIONS： The Chinese legislature should draw useful legal experiences from USA to establish suitable legal measures to regulate and control the financial conflict of interest of researchers in clinical trials, clarify the definition of the financial interest of researchers, require the applicant for clinical trial to disclose his financial interest and the applicants for drug registration to submit the statement about the financial conflict of interest of researchers to the drug administration department.